Z-0646-2016 Class II Terminated
FDA device recall Z-0646-2016 was initiated by Zimmer Biomet, Inc. on Dec 9, 2015 and is designated Class II. Reason for recall: Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot… The recall status is terminated (terminated Nov 8, 2016). Affected quantity: 400.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 20, 2016
- Initiation Date
- Dec 9, 2015
- Termination Date
- Nov 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400
Product Description
Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
Reason for Recall
Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot number 62896038.
Distribution Pattern
Worldwide Distribution-US including the states of CA, NY, PA, AL, FL, GA, ID, WI, MO, SC, NC, and ME, and the countries of Brazil, Dominican Republic, Taiwan, China, Uruguay, Australia, Japan, Malaysia, India, Belgium, France, Italy, Netherlands, Poland, United Arab Emirates, and Canada.
Code Information
Item 00-2359-058-35, Lot 62918019 PERI LOCKING SCREW 3.5MM Item 00-2359-014-24, Lot 62896038 PERI LOCKING SCREW 2.4MM
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0646-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026